Hyperplastic diseases are non-malignant conditions that represent an unmet medical need. Typically, these diseases are characterized by the uncontrolled growth of cells. In many patients these cells are not malignant and the hyperplastic cells do not lead to the development of cancer. Thus, the hyperplastic cells are not treated with the conventional chemotherapeutic agents useful against malignant diseases.
One example of a hyperplastic disease is benign prostatic hypertrophy (BPH). This disease is characterized by the abnormal growth of the prostate. Substantial data currently exist showing that prostate volume increases with age in a measurable group of middle-aged and older men, following a post-pubertal plateau. In addition, the incidence and prevalence of prostate disease increase with age, and are very high in elderly men (>40%). Other non-malignant hyperplastic diseases include, but are not limited to fibroplastic dysplasia of the breast, fibroplastic growths in the uterus or cervix, and gastric hyperplastic polyposis. In many patients, hyperplastic diseases do not lead to the development of cancer, and are not treated with the conventional chemotherapeutic agents used against malignant diseases.
Therefore, a continuing need exists for new, potent, and selective agents useful to prevent detrimental effects or control the growth of hyperplastic cells.